Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome

This study has been completed.
Sponsor:
Collaborators:
Laerdal Medical
Ullevaal University Hospital
Health Region East, Norway
Norwegian Air Ambulance Foundation
University of Oslo
Information provided by (Responsible Party):
Petter Andreas Steen, University of Oslo
ClinicalTrials.gov Identifier:
NCT00121524
First received: July 13, 2005
Last updated: May 28, 2015
Last verified: May 2015
  Purpose

Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.


Condition Intervention Phase
Cardiac Arrest
Drug: Epinephrine
Device: Intravenous needle
Drug: Atropine
Drug: Amiodarone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Epinephrine and I.V. Needle on CPR Outcome

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • survival to hospital discharge with neurologic outcome [ Time Frame: discharge from hospital ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • admit to hospital with spontaneous circulation [ Time Frame: hospital admission ] [ Designated as safety issue: No ]
  • one year survival with neurologic outcome [ Time Frame: one year after hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment: 904
Study Start Date: January 2003
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV yes
Intravenous needle Epinephrine q 3 min during CPR Atropine 3 mg in initial asystole Amiodarone 300 mg iv after repeated failed defibrillation attempts
Drug: Epinephrine
Epinephrine 1 mg is given iv. every 3 min during CPR
Other Name: Adrenaline
Device: Intravenous needle
An intravenous needle in placed as soon as possible during CPR
Drug: Atropine
Atropine 3 mg iv in initial systole
Other Name: Atropine sulfate
Drug: Amiodarone
amiodarone 300 mg iv after repeated failed defibrillation attempts
Other Name: Amiodaron
No Intervention: IV no
The patient will not have an intravenous needle placed or given any drugs during CPR. If patient obtains spontaneous circulation, an intravenous needle is placed and patient can receive any drugs that are appropriate during the following treatment.

Detailed Description:

In a randomized, controlled study of all out-of-hospital cardiac arrest patients in Oslo, Norway, half the patients are treated according to the international guidelines for advanced CPR, and the other half according to the same guidelines, except for no I.V. needle or drugs are given until 5 minutes after eventual return of spontaneous circulation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac arrest out-of-hospital

Exclusion Criteria:

  • <18 years old
  • Trauma as cause of arrest
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121524

Locations
Norway
Ulleval University Hospital
Oslo, Norway, N-0407
Sponsors and Collaborators
Petter Andreas Steen
Laerdal Medical
Ullevaal University Hospital
Health Region East, Norway
Norwegian Air Ambulance Foundation
University of Oslo
Investigators
Principal Investigator: Lars Wik, MD, PhD Ullevaal University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Petter Andreas Steen, Professor Acute Medicine, University of Oslo
ClinicalTrials.gov Identifier: NCT00121524     History of Changes
Other Study ID Numbers: 525-02201
Study First Received: July 13, 2005
Last Updated: May 28, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
cardiac arrest
resuscitation
epinephrine
intravenous
survival

Additional relevant MeSH terms:
Heart Arrest
Cardiovascular Diseases
Heart Diseases
Amiodarone
Atropine
Epinephrine
Epinephryl borate
Racepinephrine
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2015